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PTC Therapeutics Reports Third Quarter 2013 Financial and Corporate Results
Date:11/14/2013

clinical trial evaluating our investigational new drug ataluren as a potential treatment for patients with nonsense mutation Duchenne muscular dystrophy (nmDMD). The study is on-track to complete enrollment by mid-2014. The Phase 3 study is expected to be conducted at 53 clinical sites across 18 countries.
  • EMA regulatory process progressing: Following the October 2012 submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for conditional approval of ataluren in nmDMD, the regulatory process continues to progress.  The Committee for Medicinal Products for Human Use (CHMP) has recently notified us that it intends to convene a Scientific Advisory Group (SAG) meeting as part of the regulatory review process.  The SAG meeting may shift the timing of a final opinion from the CHMP on the conditional approval of ataluren in nmDMD from the last quarter of 2013 to the first quarter of 2014.  To manage our regulatory priorities, PTC also plans to delay the filing of an MAA for conditional approval of ataluren in nonsense mutation cystic fibrosis (nmCF) until the first quarter of 2014.
  • Third Quarter 2013 Financial Highlights:

  • Cash, cash equivalents, and marketable securities totaled $157.2 million at September 30, 2013 compared to $2.7 million at December 31, 2012.  The increase was primarily a result of receiving net proceeds of $60.8 million from PTC's equity private placement and $131.6 million from PTC's initial public offering in the first half of 2013 combined with a $10 million milestone achieved in the third quarter of 2013 from Roche for the selection of a development candidate in our SMA collaboration.
  • Revenue from grants and collaborations was $16.3 million for the third quarter of 2013, compared to $7.2 million for the same period in 2012.  The increase was primarily the result of the achievement of a $10 million milestone in our Roche collaboration. Collaborati
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  • SOURCE PTC Therapeutics, Inc.
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